New York Proposes New PBM Regulations
The New York State Department of Financial Services has proposed new rules surrounding pharmacy benefit managers (PBMs) that deal with establishing definitions; licensing; contracting with pharmacies; acquisition of PBMs; consumer protections and audit regulations regarding PBMs.
The New York State Department of Financial Services has proposed new rules surrounding pharmacy benefit managers (PBMs) that deal with establishing definitions; licensing; contracting with pharmacies; acquisition of PBMs; consumer protections and audit regulations regarding PBMs.
This rulemaking is one to monitor especially with the recent events from the 10th Circuit. We have written a recent blog post on this developments surrounding this decision.
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying efforts help pharmacies nationwide achieve improved business climates through carefully crafted legislation as well as counseling clients on responding to relevant proposed rules.
If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.
Biden Administration Announces First Ten Drugs Selected for Medicare Price Negotiation
The Biden Administration has announced today that Medicare will be able to negotiate drug prices for the first time due to provisions within the Inflation Reduction Act.
The Biden Administration has announced today that Medicare will be able to negotiate drug prices for the first time due to provisions within the Inflation Reduction Act.
The first ten selected drugs for negotiation are Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara and Fiasp.
The Administration stated that these drugs “accounted for $50,5 billion in total Part D gross covered prescription drug costs. The negotiations will occur in 2023 and 2024 and any negotiated prices will become effective beginning in 2026.
According to HHS press release read here, “In future years, CMS will select for negotiation up to 15 more drugs covered under Part D for 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after that, as outlined in the Inflation Reduction Act.”
Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
More Drugmakers Sue Biden Administration Over Medicare Negotiation
Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violates the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.
Johnson and Johnson has filed a lawsuit in New Jersey federal district court, arguing that the new powers granted to Medicare to negotiate drug prices violate the First and Fifth Amendments of the U.S. Constitution. Medicare’s new power to negotiate comes from the recently enacted Inflation Reduction Act (IRA). Earlier suits by Merck, Bristol Myers Squibb, the U.S. Chamber of Commerce and PhRMA have made similar arguments.
As part of the new law, the Centers for Medicare and Medicaid Services (CMS) will publish a list of which drugs were selected for a first cycle of negotiations on Sept. 1, with prices taking effect in 2026. The companies that make those drugs face an October deadline to sign agreements to participate in those negotiations.
Lanton Law is a national boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments in the healthcare and life science spaces. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
Lanton Law Speaks at Summit & Reverse Expo
We were pleased to be invited to Orlando, Florida to speak with IDN with our presentation titled “Price, Innovation & Policy: What’s on the Horizon for the Industry.
We were pleased to be invited to Orlando, Florida to speak with IDN with our presentation titled “Price, Innovation & Policy: What’s on the Horizon for the Industry.
House Passes Insulin Bill
The U.S. House of Representatives has passed the Affordable Insulin Now Act seen here.
The U.S. House of Representatives has passed the Affordable Insulin Now Act seen here. According to the bill’s summary this bill does the following:
Limits cost-sharing for insulin under private health insurance and the Medicare prescription drug benefit.
Caps cost-sharing under private health insurance for a month's supply of selected insulin products at $35 or 25% of a plan's negotiated price (after any price concessions), whichever is less, beginning in 2023.
Caps cost-sharing under the Medicare prescription drug benefit for a month's supply of covered insulin products at $35 beginning in 2023.
Currently, the Centers for Medicare & Medicaid Services is testing a voluntary model under the Medicare prescription drug benefit (the Part D Senior Savings Model) in which the copayment for a month's supply of insulin is capped at $35 through participating plans. The model is set to expire on December 31, 2025.
The bill also (1) further delays implementation of regulations relating to the treatment of certain Medicare prescription drug benefit rebates from drug manufacturers for purposes of federal anti-kickback laws, and (2) increases funding for the Medicare Improvement Fund.
The bill now goes to the Senate where 60 votes are needed to send it to the President.
Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our healthcare practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.
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CMS Proposes Rescinding Most Favored Nation Interim Final Rule
The Centers for Medicare and Medicaid Services (CMS) has released a proposed rule that seeks to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020 Federal Register. CMS is seeking public comment by October 12, 2021.
The Centers for Medicare and Medicaid Services (CMS) has released a proposed rule that seeks to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020 Federal Register. CMS is seeking public comment by October 12, 2021.
This rule has already had some interesting history. According to the proposal, “In December 2020, while the comment period was open, four lawsuits were filed related to CMS's waivers of proposed rulemaking and delay in effective date as well as other aspects of the MFN Model and the November 2020 interim final rule.
On January 8, 2021, the Solicitor General determined not to appeal the preliminary injunction issued in California Life Sciences. On January 19, 2021, at the parties' request, the U.S. Northern District of California stayed the case until at least April 23, 2021. Subsequently, on April 26, 2021, another stay was granted until July 26, 2021. On July 29, 2021, another stay was granted until September 27, 2021.
In Regeneron Pharmaceuticals, on February 2, 2021, the plaintiff filed a letter seeking leave to file a motion for summary judgment, and HHS filed a letter seeking leave to file a motion for a stay. On February 10, 2021, the U.S. District Court for the Southern District of New York granted HHS's request and stayed the case for 90 days (that is, through May 11, 2021). On May 10, 2021, the stay in this case was extended for an additional 90 days, until August 9, 2021, to give HHS time to consider how to proceed with the rule in light of the “unanimous” court decisions to date. In its order, the court noted that HHS should “not assume that another stay will be granted,” as the stays gave HHS “a half-year to reach a conclusion regarding how to proceed[.]”
As a result of the nationwide preliminary injunction, the MFN Model was not implemented on January 1, 2021, as contemplated in the November 2020 interim final rule. While the nationwide preliminary injunction has been in place, CMS considered how to proceed given stakeholders' concerns about potential impacts of the MFN Model.”
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology.
If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.
NCPA Files Lawsuit on Pharmacy Direct & Indirect Remuneration (DIR) Fees
The National Community Pharmacists Association (NCPA) has filed a lawsuit against the U.S. Department of Health & Human Services (HHS) on DIR fees. Specifically, the complaint seeking declaratory and injunctive relief seeks three things according to NCPA’s release:
The National Community Pharmacists Association (NCPA) has filed a lawsuit against the U.S. Department of Health & Human Services (HHS) on DIR fees. Specifically, the complaint seeking declaratory and injunctive relief seeks three things according to NCPA’s release:
The rule’s definition of “negotiated price” violates the plain language and intent of Congress when they passed legislation creating the Medicare Part D program.
The rule is invalid as arbitrary and capricious. In 2014 CMS said that the “reasonably determined” exception leading to DIR fees would be “narrow,” but comment letters showed that not to be the case.3 A recent study showed that pharmacy DIR fees have increased 1600% since 2015, with $4 billion in DIR fees being squeezed from pharmacies in 2017 alone.
The Final Rule Was Not Adopted Through Proper Notice-and-Comment Rulemaking. The proposed rule defined negotiated prices to include all price concessions from pharmacies and did not discuss or address any exceptions. In the final rule, without giving interested parties notice or the opportunity to comment, CMS created the exception for price concessions that could not be reasonably determined at the point of sale.
HHS did file a motion to dismiss available here.
Lanton Law will continue to monitor the developments of this important case.
Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life science and technology. Our pharmacy practice has been helping pharmacies nationwide with operational issues, mergers and acquisitions, regulatory inquiries, audits, licensure, employment issues and contracting. Our lobbying entity (Lanton Strategies) is helping pharmacies nationwide achieve improved business climates through carefully crafted legislation.
If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions,contact us today.
New White House Drug Pricing Executive Order Released
On September 13, 2020, the Trump Administration released a new Executive Order (EO) targeting drug pricing.
On September 13, 2020, the Trump Administration released a new Executive Order (EO) targeting drug pricing. The EO directs the Secretary of HHS to implement a “Most Favored Nation” drug pricing program for Medicare Parts B and D. This policy relies on international price competition and seeks to provide Americans with the same lower prices for prescriptions that we see in other countries.
Drug pricing has been a major point of contention as manufacturers and insurer/pharmacy benefit managers exchange blame over why drug prices are rising. Drug pricing has been a major issue that had been getting Congressional scrutiny until COVID-19.
This issue will come back once a COVID-19 vaccine is available as there may be questions around the vaccine’s price. Additionally, once COVID-19 dies down, drug pricing for new therapies is expected to be front and center again.
Lanton Law is a national boutique law and government affairs firm that focuses on healthcare and technology. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today!
Lanton Law Speaks with Pharmacy Times about U.S. Supreme Court Case Rutledge v. PCMA & Its Implication on Pharmacy Policy
Lanton Law was interviewed by Pharmacy Times on the implications of the October 6, 2020 U.S. Supreme Court case of Rutledge v. PCMA.
Lanton Law was interviewed by Pharmacy Times on the implications of the October 6, 2020 U.S. Supreme Court case of Rutledge v. PCMA. This case has major consequences for future PBM policies. Click here to access the interview.
New Executive Order Aimed at Pharmacy Benefit Managers (PBMs)
The White House has released an Executive Order titled “Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen.”
The White House has released an Executive Order titled “Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen.”
“One of the reasons pharmaceutical drug prices in the United States are so high is because of the complex mix of payers and negotiators that often separates the consumer from the manufacturer in the drug-purchasing process. The result is that the prices patients see at the point-of-sale do not reflect the prices that the patient’s insurance companies, and middlemen hired by the insurance companies, actually pay for drugs. Instead, these middlemen — health plan sponsors and pharmacy benefit managers (PBMs) — negotiate significant discounts off of the list prices, sometimes up to 50 percent of the cost of the drug.”
This Executive Order advocates for HHS to complete its prior January 2019 proposed rule aimed at “revising the discount safe harbor to explicitly exclude from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D, Medicaid managed care organizations as defined under section 1903(m) of the Act (Medicaid MCOs), or pharmacy benefit managers (PBMs) under contract with them.”
Not only does this Executive Order state that discounts offered on prescription drugs should be passed on to patients, but that HHS must confirm publicly prior to finalizing its proposed rule that “that the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs.”
Lanton Law is a national boutique law and government affairs firm that focuses on healthcare/life sciences, technology and finance. If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.
Lanton Law Interviews the Massachusetts Pharmacists Association on DIR & Provider Status
We are excited to have Lindsay De Santis; Executive Vice President of the Massachusetts Pharmacists Association (MPhA) do a blogcast with us. Our conversation covers pharmacy DIR (direct and indirect remuneration) fees, pharmacy provider status and COVID-19.
We are excited to have Lindsay De Santis; Executive Vice President of the Massachusetts Pharmacists Association (MPhA) do a blogcast with us. Our conversation covers pharmacy DIR (direct and indirect remuneration) fees, pharmacy provider status and COVID-19.
Click here to access the Lanton Law blogcast.